FDA 510(k) Applications Submitted by Kettenbach GmbH & Co. KG

FDA 510(k) Number	Submission Date	Device Name	Applicant
K230333	02/07/2023	Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)	Kettenbach GmbH & Co. KG
K191523	06/10/2019	Visalys Restorative Primer	Kettenbach GmbH & Co. KG
K191524	06/10/2019	Visalys Tooth Primer	Kettenbach GmbH & Co. KG
K191527	06/10/2019	Visalys CemCore, Visalys Cem Core Try In Paste	Kettenbach GmbH & Co. KG
K250267	01/30/2025	Visalys« Bulk Fill 1 x 4 g Syringe (15060); Visalys« Bulk Fill 15 x 0.25 g Caps (15062); Visalys« Bulk Flow 1 x 2 g Syringe (15064); Visalys« Bulk Flow 15 x 0.25 g Caps (15066); Visalys« Bulk Flow Intro pack (15067); Visalys« Bulk Intro pack (15068)	Kettenbach GmbH & Co. KG